Blankets recalled after MRI injury

ระวัง ! ผ้าห่มพิเศษสำหรับป้องกันภาวะ hypothermia แก่ผู้ป่วย ห้ามนำเข้าห้อง MRI

The Encompass Group said its Thermoflect blankets should not be used in MRI procedures after the U.S. Food and Drug Administration (FDA) reported an injury to an MRI patient.

The McDonough, GA-based company issued the recall December 26, advising customers that its products should not be used in "MR-conditional or MR-compatible environments." But the blankets are still safe for use in treating hypothermia, a press released noted.

There is no evidence the blankets caused the injury, according to the company, but as a "precautionary measure" Encompass will re-label the product.

The patient suffered third-degree burns, but company spokeswoman Jea Gackowski noted that the blankets have been used for 17 years in MRI procedures with no prior problems.

 

Ref.

By AuntMinnie.com staff writers
December 30, 2009

Press Release: MR Environment Recall      

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Note

Hypothermia :   is a core body temperature of less than 36°C (96.8°F). The three levels of hypothermia:

• Mild: 32°C - 36°C (89°F - 96.8°F),
• Moderate: 30°C - 32°C (86°F - 89°F),
• Severe: < 30°C (<86°F)